510(k) · Cleared
Recalled · Class II · 2012Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · OWB Interventional Fluoroscopic X-Ray System
Cleared on Feb 22, 2006 as substantially equivalent to K052412 (GE Healthcare, 2005) and 3 other predicates after a 21-day review. Its family tree reaches back 6 generations to 1989. 47 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 22, 2006
- Review
- 21 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 6 generations to K890348 (1989). 16 ancestors in all. 47 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 5 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 4 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 3 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 2 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 1 generation backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- This deviceK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006
- Descendant · cites it directly · 23 of its ownK081582 Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · Recalled
- Descendant · cites it directly · 22 of its ownK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- Descendant · 2 generations on · 21 of its ownK101868 Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010
- Descendant · 3 generations on · 20 of its ownK120073 Infx-8000V withToshibamedical Systems Corporation · 2012 · Recalled
- Descendant · cites it directly · 11 of its ownK091658 GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models…GE Healthcare · 2009 · Recalled
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K081582Infx-8000V, Infinix-Cfi and Infinix VfiToshiba America Medical Systems, In.C · 2008 · cites it directly23descendants
- K061163Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ…Ge Medical Systems, LLC · 2006 · cites it directly22descendants
- K101868Infinix-I Interventional Angiography System Model Infx-8000VToshiba America Medical Systems, In.C · 2010 · 2 generations on21descendants
- K120073Infx-8000V withToshibamedical Systems Corporation · 2012 · 3 generations on20descendants
- K091658GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100…GE Healthcare · 2009 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −5 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −4 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −3 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −2 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −1 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| 0 (this device) | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | — |
| +1 | K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | Toshiba America Medical Systems, In.C | 2008 | 1 |
| +1 | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova… | Ge Medical Systems, LLC | 2006 | 38 |
| +2 | K101868 | Infinix-I Interventional Angiography System Model Infx-8000V | Toshiba America Medical Systems, In.C | 2010 | — |
| +3 | K120073 | Infx-8000V with | Toshibamedical Systems Corporation | 2012 | 3 |
| +1 | K091658 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova… | GE Healthcare | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OWB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQSummary page 1…e, WI The Innova 3131'? (3131-1Q) and 2121'? (2121-1Q) are substantially equivalent respectively to the currently marketed Vascular Angiographic systems Innova 31 00'® (K052412) and Innova 2100™ (K050489) and comply with the same or equivalent standards. Biptane feature is substantially equivalent respe… | 2005 |
| * | K050489 | Innova 2100Summary page 1…131-1Q) and 2121'? (2121-1Q) are substantially equivalent respectively to the currently marketed Vascular Angiographic systems Innova 31 00'® (K052412) and Innova 2100™ (K050489) and comply with the same or equivalent standards. Biptane feature is substantially equivalent respectively to the Advantx LCN+… | 2005 |
| * | K974367 | Advantx LCN, Advantx LCLPSummary page 1…) and comply with the same or equivalent standards. Biptane feature is substantially equivalent respectively to the Advantx LCN+ and Advantx LC/LP+ (both cleared under K974367). Tilt table Elegance option is substantially equivalent to the Digital Fluoroscopic Imaging System, Model Innova K033244. The.… | 1998 |
| * | K033244 | Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table OptionSummary page 1…tx LCN+ and Advantx LC/LP+ (both cleared under K974367). Tilt table Elegance option is substantially equivalent to the Digital Fluoroscopic Imaging System, Model Innova K033244. The. Digital Fluoroscopic Imaging Systems are designed to perform biplane fluoroscopic x-ray examinations. The detectors are co… | 2003 |
What descends from it? (47)
See all 474 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081582 | Infx-8000V, Infinix-Cfi and Infinix Vfi | 2008 | 23 |
| K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ… | 2006 | 22 |
| K091658 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova 4100, 3100… | 2009 | 11 |
| K092004 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQ | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 16, 2012 | Class II | Z-2376-2012 | Software design | GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a… |
| Oct 14, 2009 | Not classified | Z-0540-2010 | Employee error | GE Healthcare has become aware of a potential limit switch failure with Innova 2121IQ and 3131IQ (Biplane) systems that may impact patient safety. A potential limit switch failure could occur due to collision between the lateral plane of… |
| Apr 16, 2009 | Not classified | Z-0138-2010 | Device Design | Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room… |
| Nov 21, 2008 | Not classified | Z-1195-2009 | Device Design | GE Healthcare has become aware of a potential image storage failure on Innova 2121 IQ/ 3131 IQ cardiovascular imaging systems that may impact patient safety. This intermittent communication failure on the image storage chain may result in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 12 of the 16 ancestors have a recall of any class.
- Of its descendants, K081582 (Toshiba America Medical Systems, In.C, 2008) has gone furthest, with 23 descendants of its own.
- 7 other devices also cite its predicate K052412.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The Innova 3131 (3131-1Q) and 2121 (2121-1Q) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K060259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060259: Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060259
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026